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INSM FDA decision dates

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

INSM has 1 upcoming FDA decision date; the nearest is Jan 28, 2027 for ARIKAYCE (amikacin liposome inhalation suspension) - MAC lun. 1 past decision is on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

INSM catalyst hub · full calendar

Upcoming

Jan 28, 2027 in 84 daysARIKAYCE (amikacin liposome inhalation suspension) - MAC lung disease

Decided

Aug 12, 2025 ✓ ApprovedBRINSUPRI
Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
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